NCT06798532

Brief Summary

Neuroblastic tumors (NBTs) develop from neural crest cells that give rise to the sympathetic nervous system. They include neuroblastomas, ganglioneuroblastomas, and ganglioneuromas. They represent approximately 10% of solid tumors in children under 15 years of age. In 15 to 20% of cases, NBTs are located in the thoracic region. These paravertebral tumors have an extracanal component and some also have an intraspinal component (dumbbell tumors) that can cause spinal cord compression. Surgery for these tumors also exposes the patient to neurological complications. In the thorax, the basi-thoracic location (T9-T12) may be particularly at risk due to the presence of the artery of Adamkiewicz (AKA), which supplies blood to the spinal cord; damage to this artery can result in spinal cord ischemia. To avoid this scenario, some teams recommend performing spinal cord arteriography to identify AKA. However, many centers do not perform arteriography and do not report more postoperative complications. Currently, there is no consensus on the indications for performing preoperative spinal arteriography in patients undergoing surgery for basi-thoracic NBT. This study evaluates the practice in France of preoperative arteriography to identify the AKA among patients undergoing surgery for basi-thoracic neuroblastic tumors and analyzes the incidence of postoperative neurological complications in these patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2025

Shorter than P25 for all trials

Geographic Reach
1 country

27 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 29, 2025

Completed
8 months until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

September 12, 2025

Status Verified

September 1, 2025

Enrollment Period

6 months

First QC Date

January 17, 2025

Last Update Submit

September 5, 2025

Conditions

Keywords

Neuroblastic tumorsNeuroblastomasGanglioneuroblastomasGanglioneuromasAdamkiewicz ArteryPediatric surgery

Outcome Measures

Primary Outcomes (1)

  • Occurrence of neurological complications secondary to spinal cord ischemia

    Assessment of postoperative neurological complications in patients undergoing surgery for basi-thoracic NBT, with or without preoperative spinal cord arteriography.

    2005 to 2024

Secondary Outcomes (2)

  • Demographic characteristics of patients undergoing surgery for basithoracic neuroblastic tumor

    2005 to 2024

  • Outcome of patients undergoing surgery for basithoracic neuroblastic tumor

    2005 to 2024

Study Arms (1)

Pediatric patients

Patients undergoing surgery for a neuroblastic tumor (neuroblastoma, ganglioneuroblastoma) with basi-thoracic location between T8 and L1, with or without intraspinal component and treated in a pediatric surgery department in France between 2005 and 2024.

Other: Collection of data from the patient's medical file.

Interventions

Collection of data from the patient's medical file.

Pediatric patients

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing surgery for a neuroblastic tumor in a pediatric surgery department in France between 2005 and 2024 and meeting the inclusion criteria.

You may qualify if:

  • Patients undergoing surgery for a neuroblastic tumor (neuroblastoma, ganglioneuroblastoma, ganglioneuroma)
  • Basithoracic location between T8 and L1
  • With or without intraspinal component
  • Treated in a pediatric surgery department in France
  • Between 2005 and 2024
  • Adult patients or holders of parental authority of minor patients informed and not opposed to the use of data for the study

You may not qualify if:

  • \. Post-operative follow-up of less than 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (27)

CHU d'Amiens

Amiens, 80000, France

Location

CHU de Besançon

Besançon, 25000, France

Location

CHU de Bordeaux

Bordeaux, 33000, France

Location

CHU de Brest

Brest, 29200, France

Location

CHU de Lyon

Bron, 69677, France

Location

CHU de Caen

Caen, 14000, France

Location

CHU de Dijon

Dijon, 21079, France

Location

CHU de Grenoble

Grenoble, 38000, France

Location

Hôpital Bicêtre

Le Kremlin-Bicêtre, 94270, France

Location

CHU de Lille

Lille, 59000, France

Location

CHU de Limoges

Limoges, 87000, France

Location

CHU de Marseille

Marseille, 13005, France

Location

CHU de Montpellier

Montpellier, 34090, France

Location

CHU de Nancy

Nancy, 54100, France

Location

CHU Nantes

Nantes, 44000, France

Location

CHU Nice

Nice, 06200, France

Location

Hôpital Trousseau

Paris, 75012, France

Location

Hôpital Necker enfants malades

Paris, 75015, France

Location

Hôpital Robert Debré

Paris, 75019, France

Location

CHU de Poitiers

Poitiers, 86000, France

Location

CHU de Reims

Reims, 51100, France

Location

CHU de Rennes

Rennes, 35203 CEDEX 2, France

Location

CHU de Rouen

Rouen, 76000, France

Location

CHU de La Réunion

Saint-Denis, 97405, France

Location

CHU de Strasbourg

Strasbourg, 671091, France

Location

CHU de Toulouse

Toulouse, 31059 cedex 9, France

Location

CHU de Tours

Tours, 37000, France

Location

Related Publications (7)

  • Lindeire S, Hauser JM. Anatomy, Back, Artery of Adamkiewicz. 2025 Mar 25. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK532971/

    PMID: 30422566BACKGROUND
  • Nordin AB, Fallon SC, Jea A, Kim ES. The use of spinal angiography in the management of posterior mediastinal tumors: case series and review of the literature. J Pediatr Surg. 2013 Sep;48(9):1871-7. doi: 10.1016/j.jpedsurg.2013.04.029.

    PMID: 24074660BACKGROUND
  • Schmidt A, Hempel JM, Ellerkamp V, Warmann SW, Ernemann U, Fuchs J. The Relevance of Preoperative Identification of the Adamkiewicz Artery in Posterior Mediastinal Pediatric Tumors. Ann Surg Oncol. 2022 Jan;29(1):493-499. doi: 10.1245/s10434-021-10381-8. Epub 2021 Jul 31.

    PMID: 34331163BACKGROUND
  • Bosmia AN, Hogan E, Loukas M, Tubbs RS, Cohen-Gadol AA. Blood supply to the human spinal cord: part I. Anatomy and hemodynamics. Clin Anat. 2015 Jan;28(1):52-64. doi: 10.1002/ca.22281. Epub 2013 Jun 27.

    PMID: 23813725BACKGROUND
  • De Bernardi B, Gambini C, Haupt R, Granata C, Rizzo A, Conte M, Tonini GP, Bianchi M, Giuliano M, Luksch R, Prete A, Viscardi E, Garaventa A, Sementa AR, Bruzzi P, Angelini P. Retrospective study of childhood ganglioneuroma. J Clin Oncol. 2008 Apr 1;26(10):1710-6. doi: 10.1200/JCO.2006.08.8799.

    PMID: 18375900BACKGROUND
  • Furak J, Geczi T, Tiszlavicz L, Lazar G. Postoperative paraplegia after resection of a giant posterior mediastinal tumour. Importance of the blood supply in the upper spinal cord. Interact Cardiovasc Thorac Surg. 2011 May;12(5):855-6. doi: 10.1510/icvts.2010.257105. Epub 2011 Feb 8.

    PMID: 21303870BACKGROUND
  • Boglino C, Martins AG, Ciprandi G, Sousinha M, Inserra A. Spinal cord vascular injuries following surgery of advanced thoracic neuroblastoma: an unusual catastrophic complication. Med Pediatr Oncol. 1999 May;32(5):349-52. doi: 10.1002/(sici)1096-911x(199905)32:53.0.co;2-p.

    PMID: 10219336BACKGROUND

MeSH Terms

Conditions

NeoplasmsNeuroblastomaGanglioneuroblastomaGanglioneuroma

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors, Primitive, PeripheralNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • Marianna MD Cornet

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR
  • Sabine MD, PhD Sarnacki

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sabine MD, PhD Sarnacki

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2025

First Posted

January 29, 2025

Study Start

October 1, 2025

Primary Completion

April 1, 2026

Study Completion

April 1, 2026

Last Updated

September 12, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations